CYCLOBENZAPRINE HYDROCHLORIDE | A091281 | TWI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teva Pharmaceuticals FDA-2016-P-1873 · 7 docket documents Teva Pharmaceuticals filed this petition under 21 USC 355(q) requesting that the FDA require any ANDA for cyclobenzaprine hydrochloride extended-release capsules referencing AMRIX to conduct a bioequivalence study demonstrating that the proposed generic product is bioequivalent to AMRIX when adminis | 505(q) | 2016-07-01 | Partially Denied | Teva Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.47
per ea
Lowest NADAC/Unit
$1.18
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 24979003604CYCLOBENZAPRINE ER 30 MG CAP | $1.47 | EA | Generic | — | 2026-10-21 |
| 24979003504CYCLOBENZAPRINE ER 15 MG CAP | $1.18 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.